FDA Inspection
Gland Pharma LimitedGland Pharma Limited – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns Gland Pharma Limited, with an inspection on February 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a1ce57fb-6700-494f-9a9f-b6ef80f6b697
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002974
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.68(b)Backup file not maintained
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Other FDA inspections of Gland Pharma Limited
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| July 25, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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| August 25, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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